Registration Dossier

Administrative data

Description of key information

The test substance was examined for possible sensitizing properties by a maximization test in guinea pigs using 20 test animals and 10 controls.

The test comprised of:

a. induction treatment by intradermal injection of a 10% dilution of the test substance in propylene glycol, followed one week later by a topical treatment with 25% test substance in vaseline;

b. challenge treatment, 14 days after the last induction, by topical application of 10% test substance in vaseline.

The challengde treatment with the 10% dilution showed evidence of delayed contact hypersensitivity. From the results of the challenge treatment with the 10% dilution it appeared that the test substance induced skin reactions in 16 out of 20 test animals, while also in 2 out of 10 controls showed dermal reactions. Since, only very slight skin reactions were observed in controls the very slight skin reactions seen in the test animals are considered due to irritation rather than the senisitzation. However, the more severe reactions observed in 6 out of 20 animals are possible due to sensitization. Therefore, the test substance is considered to be a moderate sensitizer.

It was concluded that the test substance is a moderate sensitizer.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Severe skin reactions were observed in 6 out of 20 animals (30%) that are possible due to sensitization. Therefore, it was concluded that the test substance is a moderate sensitizer.